Services

Health care regulatory services

Providing advisory services across the health care ecosystem

By focusing on the differentiated needs of plans and providers, our US Health Care practice can help clients transform uncertainty into possibility, and rapid change into lasting progress. We look deeper at the biggest industry regulatory and compliance issues and provide cutting-edge research to give you the insights you need to see things differently.

Inflation Reduction Act of 2022

Signed into law on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) establishes new measures and regulatory authorities to control drug costs across the Medicare program.

The IRA provisions, especially those regulating drug prices, will have broad-reaching impact on life sciences and health care stakeholders, including health plans, hospitals, biopharma manufacturers, the federal government, and employers. This new law marks the first significant changes to Medicare drug policy since the Medicare Modernization Act of 2003. It also includes important changes that directly impact consumers in two ways: it will drive down costs for Medicare beneficiaries, primarily through closure of the “donut hole,” and will extend the Affordable Care Act’s premium tax credits to help individuals who purchase health insurance coverage on the exchanges.

Learn more

Compliance challenges for the health care industry

${tab-1-img-alt}

Given the complexities and highly regulated nature of health care in the United States, we bring a team of advisers experienced in client service across the health care continuum who have worked extensively on matters involving government regulatory agencies. Whether assessing and building effective compliance programs or executing on annual auditing and monitoring objectives, our team helps clients of all sizes to manage the risks associated with noncompliance with federal and state regulations through services such as:

• Compliance program management

• Specialized compliance internal audit

• Privacy program and data management

${tab-2-img-alt}

In the US health care system, regulatory disruption is often viewed as a hinderance to growth, progress, and revenue. However, as the future of health becomes a greater focus for businesses and regulators alike, health care organizations can capture opportunity from emerging policy change to strengthen their revenue streams and ultimately drive better health outcomes. Our Health Care Regulatory Support team helps organizations to identify potential regulatory challenges and assists them in designing and implementing leading practices to increase opportunities in areas such as:



• Strategic regulatory implementation

• Clinical documentation integrity

• Charge capture services and clinical data management

• Coronavirus Aid, Relief, and Economic Security Act (CARES) Act and federal COVID-19 relief funding

• 340B program

${tab-3-img-alt}

From organizational assessments to the implementation of emerging capabilities, our industry advisers help clients to build resilience by emphasizing not only compliance program functionality, but also its cost-effectiveness. Whether deploying traditional solutions, digital tools, data analytics, or automation, our professionals can assist you to strengthen your compliance and operational processes in an effort to mitigate federal program risk. Services include:



• Compliance risk assessment

• Advanced analytics and automation

• Compliance modernization

${tab-4-img-alt}

We assist organizations in operationalizing an approach to investigating potential areas of concern related to compliance with laws, regulations, guidelines, and business processes. Our team of regulatory and compliance professionals can assist you and your organization whether it be to perform preliminary assessments to identify areas of potential noncompliance, perform activities related to responding to a governing agency, or provide a detailed report outlining pertinent findings to suggest improvements. Areas of focus include:



• Corporate integrity agreement (CIA) and independent review organization (IRO) services

• Strategic compliance outsourcing

• Government audits and investigations

This section is an infogram

This message and the space it occupies will not be displayed when viewing this page either in Live, Preview, or "View as published" modes

${view-by-button-text}:

    Submit

    Cancel

    This section is an infogram

    This message and the space it occupies will not be displayed when viewing this page either in Live, Preview, or "View as published" modes

    The Medicaid program has experienced evolutionary change over the past decade of its existence. Given the expected increase in Medicaid enrollment predicted as a result of the current financial situation brought about by COVID-19, change is expected to continue. With change comes challenges to both health plans and health care providers. For plans, stringent contract requirements make operational and compliance excellence paramount. For providers, the diminished levels of reimbursement provided for Medicaid patients compel value-based portfolio strategies. As change continues, organizations will likely continue to contend with these challenges.

    Pharmacy services go beyond just getting your prescriptions filled. Pharmacies work in close coordination with health care providers, health plans, pharmaceutical companies, group purchasing organizations (GPO), wholesalers, and other pharmacies to provide their communities with seamless and timely access to medications. Additionally, the traditional role of the pharmacist continues to evolve particularly as there is an increase in:

    • The role pharmacists play in clinical decision-making

    • The use of automation and technological advancements

    • High-cost specialty medications with plan-imposed restrictions and guardrails

    As the roles of pharmacy and the pharmacist continue to evolve, it’s vital that organizations are well-informed and have adequate controls in place to comply with guidelines and rules from the multiple regulatory and other governing parties that oversee pharmacy operations. These controls help protect organizations against vulnerable areas ripe for noncompliance, including billing operations, documentation management, and controlled substance practices. Deloitte works with pharmacies and related entities across the end-to-end continuum of care to help them understand emerging guidance, assist organizations with maintaining compliance with existing governing rules, and find new sources of value to drive efficiency and growth in a competitive market.

    The past decade has seen a convergence of regulatory disruption and macro technology forces. Emerging federal requirements have the potential to be a key catalyst to ignite multiple changes in the health industry that promote higher-quality, lower-cost care. As regulators increasingly focus on giving patients agency over their health care journey, Deloitte’s Health Care Regulatory Support team is assisting clients to capitalize on these opportunities in a way that aligns with and expands upon evolving federal requirements to create strategic differentiation.

    This section is an infogram

    This message and the space it occupies will not be displayed when viewing this page either in Live, Preview, or "View as published" modes

    Close
    Seismic shifts: A future of health webcast series
    Part 2: Regulatory changes in the future of health
    false
    Close
    Interoperability and information blocking in health care
    Latest news, resources, and strategies on interoperability for electronic health records (EHR)
    false
    Close
    Health care risk leaders are keeping their heads above water for now
    But a tidal wave of new risks may force them to sink or swim
    false
    Close
    Meeting consumers’ changing needs: Moving towards the future of health
    Improving engagement in a consumer’s health care journey may help improve outcomes and reduce the cost of care
    false
    Close
    CMS proposes demonstration to reduce Part D plan risk from safe harbor changes
    Plans expected to bid under current rebate rules
    false
    Close
    The future of health
    How innovation will blur traditional health care boundaries
    false
    Close
    Six months after CARES
    Provider Relief Fund (PRF) recipients have long awaited the reporting requirement data elements that are mandated as part of receiving and attesting to PRF payments.
    false
    Close
    Health care compliance agenda: Relieve the pressure
    Facing an onslaught of challenges that have been magnified by COVID-19, compliance leaders in health care may benefit from new strategies to optimize, standardize, and digitize.
    false
    Close
    How innovative staffing can improve compliance
    Health care compliance departments that are stretched thin may be able to stretch their capabilities a little further with alternative talent models.
    false
    Close
    Greater transparency and interoperability in health care
    Uncover strategic opportunities for health systems
    false
    Close
    Hospital Price Transparency Regulation
    Market responses are varied and reflect the many strategic implications of increasing information transparency in Health Care.
    false
    Close
    Transparency in Coverage Rule
    Health plans face both market disruption and strategic opportunities as the upcoming rule seeks to pull back the curtain on information that has long been considered a “trade secret”.
    false
    Close
    Gateway Health CCO Touts Collaborative Compliance
    A FOCUS ON BUILDING RELATIONSHIPS CAN HELP FOSTER COMPLIANCE GROUNDED IN TRUST AND RESPECT.
    false

    Get in touch

     

     

    Anne Phelps | Principal
    annephelps@deloitte.com
    +1.202.297.1378
    Washington, DC


     

    Kelly Sauders | Partner
    ksauders@deloitte.com
    +1.212.436.3180
    New York, NY

       

    Kimberly Zeoli | Partner 
    kzeoli@deloitte.com
    +1.617.437.3467
    Boston, MA

     

    Thomas Delegram | Managing Director
    tdelegram@deloitte.com
    +1.412.338.7560
    Pittsburgh, PA

     

    Suzanne Whitworth | Managing Director
    swhitworth@deloitte.com
    +1.404.631.2827
    Atlanta, GA

     

    Karolyn Woo-Miles | Principal
    kwoo@deloitte.com
    +1.714.436.7886
    Costa Mesa, CA

       

     

    Deloitte's Health Care Regulatory Support practice helps clients across the health care industry. Whether traditional organizations or those entering the competitive landscape, we assist organizations in navigating emerging regulatory policy and maintaining compliance with federal rules, regulations, and leading practices.